Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

Sponsor
AstraZeneca
Study ID
NCT00256698
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fulvestrant — DRUG
    intramuscular injection 250 mg loading dose (LD) regimen
  • Anastrozole — DRUG
    1 mg oral tablet

Study Details

The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Key Dates

Start date
Jan 31, 2004
Status verified
Jul 2012
Primary completion
Apr 30, 2009
Completion
Feb 29, 2012

Study Design

Enrollment
514 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Anastrozole
  • Experimental: 2
    Anastrozole + Fulvestrant

Primary Outcome Measure

Time to Progression (TTP) [ Time Frame: RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009 ]

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